Description

Dexak is a painkiller belonging to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It is intended for use in adults.

Composition

The active substance is dexketoprofen (in the form of dexketoprofen trometamol).
1 film-coated tablet contains 25 mg of dexketoprofen.

Excipients: corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide, propylene glycol, macrogol 6000.

Dosage

Always take this medicine exactly as described in the package leaflet or as your doctor has told you.

Adults: 1 film-coated tablet (25 mg) every 8 hours. The total daily dose should not exceed 3 film-coated tablets (75 mg).
The tablets should be swallowed with a sufficient amount of water. Taking the tablets with food reduces the risk of side effects affecting the stomach or intestines.
In case of acute pain, when a faster effect is needed, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the medicine.

Dexak tablets are not intended for long-term use.

If you do not feel better or if you feel worse after 3 to 4 days, please consult your doctor.

Action

The drug has analgesic, anti-inflammatory and antipyretic effects.

Indications

The drug is used in adults for the symptomatic treatment of mild to moderate pain, e.g. muscle pain, painful menstruation, toothache.

Contraindications

Do not use Dexak if you are hypersensitive to dexketoprofen or any of the other ingredients of this medicine and if you are hypersensitive to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); you have asthma or have had asthma attacks in the past, acute allergic rhinitis (a short period of inflammation of the lining of the nose), nasal polyps (lumps inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress) or wheezing after taking acetylsalicylic acid or other NSAIDs; you have had photosensitivity reactions in the past: photoallergic or phototoxic reactions (especially redness and/or blisters on the skin exposed to sun) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels); you have a stomach and/or duodenal ulcer or bleeding from your stomach or intestines, or if you have had stomach or intestinal bleeding, ulceration or perforation in the past; you have chronic digestive problems (e.g. indigestion, heartburn); you have had stomach or intestinal bleeding or perforation due to previous use of NSAIDs used to treat pain; you have intestinal diseases associated with chronic inflammation (Crohn’s disease or ulcerative colitis); you have severe heart failure, moderate or severe kidney failure or severe liver failure; you have an excessive tendency to bleed or have bleeding disorders; you are severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhea or insufficient fluid intake.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people): nausea and/or vomiting, abdominal pain, diarrhea, indigestion (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people): dizziness, drowsiness, sleep disturbances, nervousness, headaches, palpitations, facial flushing, stomach upset, constipation, dry mouth, flatulence, rash, tiredness, pain, feeling of fever and chills, feeling unwell.

Rare side effects (may affect up to 1 in 1,000 people): stomach ulcer, bleeding or perforation of peptic ulcer, which may be seen as vomiting blood or black stools, fainting, high blood pressure, slow breathing, water retention in the limbs and peripheral swelling (e.g. swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people): anaphylactic reactions, ulceration of the skin, lips, eyes, genital areas, swelling of the face or swelling of the lips and throat, shortness of breath due to spasm of the respiratory muscles, shortness of breath, rapid heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, tinnitus, skin hypersensitivity reactions and photosensitivity of the skin, itching, kidney damage, reduced white blood cell count, reduced platelet count.

Warnings and precautions

Be careful if you have allergies or have had problems with allergies; have kidney, liver or heart problems, stroke, heart attack, blood formation disorders, lupus erythematosus, intestinal inflammation, infection, asthma.

More information in the leaflet provided with the medicine.

Keep the medicine out of the sight and reach of children, at a temperature below 30°C.

Use of other medications

Tell your doctor about all the medicines you are taking, have recently taken or are planning to take.

This information is especially important if you are taking: ACE inhibitors, diuretics and angiotensin II antagonists used to treat high blood pressure and heart disease, Pentoxifylline and oxpentifylline used to treat ulcers in chronic venous insufficiency, Zidovudine used to treat viral infections, aminoglycoside antibiotics used to treat bacterial infections, sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide) used to treat diabetes, Methotrexate used in low doses, less than 15 mg per week, quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections, Cyclosporine and tacrolimus used to treat diseases of the immune system and in transplants, Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve clots, Probenecid used to treat gout. gout, Digoxin used to treat chronic heart failure, Mifepristone used as an abortifacient (to terminate a pregnancy), antidepressants from the selective serotonin reuptake inhibitor (SSRI) group, antiplatelet drugs used to reduce platelet aggregation and the formation of blood clots, beta-blockers used to treat high blood pressure and heart disease, Tenefovir, deferasirox, pemetrexed.

Concomitant use is not recommended: acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs; Warfarin, heparin or other drugs that prevent blood clots; lithium used to treat certain mood disorders; Methotrexate (an anticancer or immunosuppressant drug) used in high doses of 15 mg per week; Hydantoin and phenytoin derivatives used to treat epilepsy; Sulfamethoxazole used to treat bacterial infections.

Taking the medicine with food and drink

Dexak tablets should be swallowed with a sufficient amount of water. Taking the tablets with food reduces the risk of side effects affecting the stomach or intestines.

However, in cases of acute pain, it is recommended to take the medication on an empty stomach, e.g. at least 30 minutes before a meal, which will allow the medication to start working faster.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Dexak should not be used during the last three months of pregnancy or while breastfeeding. During any stage of pregnancy, use of the drug should only be as directed by a doctor.

Impact on fertility

Dexak may impair female fertility and is not recommended for women planning a pregnancy or undergoing infertility treatment.

Use of the drug in children and adolescents

The medicine is intended for adults.

Driving and operating machinery

Dexak may cause dizziness and fatigue and therefore may have minor or moderate influence on the ability to drive or use machines. Caution should be exercised.